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RULE PROPOSALS
VOLUME 41, ISSUE 22
ISSUE DATE: NOVEMBER 16, 2009
LAW AND PUBLIC SAFETY
DIVISION OF CONSUMER AFFAIRS
STATE BOARD OF MEDICAL EXAMINERS
BOARD OF PHARMACY

Jointly Proposed New Rules: N.J.A.C. 13:35-6.27 and 13:39-13

Collaborative Practice

Authorized By: William Roeder, Executive Director, State Board of Medical Examiners and Joanne Boyer, Executive Director, Board of Pharmacy.
Authority: N.J.S.A. 45:14-41, 45:14-48a.(4), 45:14-61 and 45:14-62.

Calendar Reference: See Summary below for explanation of exception to calendar requirement.
Proposal Number: PRN 2009-347 .

Submit comments by January 15, 2010 to:
William Roeder, Executive Director
Board of Medical Examiners
140 East Front Street , 2nd Floor
P.O. Box 183
Trenton , N.J. 08625

and to:

Joanne Boyer, Executive Director
Board of Pharmacy
P.O. Box 45013
Newark , N.J. 07101

The joint proposal of the agencies follows:

Summary

The State Board of Medical Examiners and the Board of Pharmacy are jointly proposing new rules that establish standards of practice for physicians and pharmacists who wish to enter into collaborative practice [page=4177] agreements for the management of patients' drug related therapies. The Pharmacy Practice Act, at N.J.S.A. 45:14-41, 48a(4) and 61 through 62, authorizes the Boards to jointly promulgate rules that allow licensed physicians and licensed pharmacists in the State to enter into collaborative practice agreements. These written agreements allow participating physicians and pharmacists to engage in collaborative drug therapy management, defined in the Board of Medical Examiners proposed new rule N.J.A.C. 13:35-6.27, and in the Board of Pharmacy proposed new subchapter N.J.A.C. 13:39-13, as the cooperative management of a patient's drug, biological and device-related health care needs.

Collaborative drug therapy management allows pharmacists to work with physicians, pursuant to written practice protocols jointly developed by the physician and the pharmacist, to solve a patient's medication-related problems. Pharmacists providing drug therapy management share responsibility for a patient's drug therapy care with the collaborating physician. The proposed new rules require that individual patients formally consent to having their drug therapy managed under a collaborative arrangement between their physician and a pharmacist. The Board of Medical Examiners and the Board of Pharmacy believe that collaborative practice agreements will enable physicians and pharmacists to more efficiently and effectively manage a patient's drug therapy needs, which may enhance the overall quality of patient care throughout the State.

Proposed new rules N.J.A.C. 13:35-6.27(b) and 13:39-13.1 provide that a physician may enter into a collaborative practice agreement with a pharmacist, provided the collaboration that the physician agrees to conduct with the pharmacist is within the scope of the physician's practice and the pharmacist is authorized to engage in such activities by the Board of Pharmacy. Board of Pharmacy proposed new rule N.J.A.C. 13:39-13.3 requires a pharmacist wishing to participate in a collaborative practice agreement to be pre-approved by the Board of Pharmacy to engage in such activities. In order to obtain Board of Pharmacy approval, the pharmacist must have a Doctor of Pharmacy Degree or be currently certified or credentialed in the pharmacy practice area that will be covered by the collaborative practice agreement. In addition, a pharmacist may qualify for Board approval to enter into collaborative practice if he or she has a minimum of 2,000 hours of documented work experience in a clinical practice setting or in a specialty pharmacy that is specific to the area of practice that will be covered by the agreement. A pharmacist approved to engage in collaborative drug therapy management must complete a minimum of 10 credits of continuing education every biennial renewal period in the practice area covered by the collaborative practice agreement.

A physician and pharmacist who engage in collaborative practice must submit a signed copy of the agreement upon request to their respective Boards, pursuant to proposed new rules N.J.A.C. 13:35-6.27(c) and 13:39-13.4. The signed agreement must, at a minimum, identify each physician and each pharmacist who is permitted to participate in a patient's collaborative drug therapy management, and the functions and responsibilities that may be performed by the pharmacist under the agreement. A sample collaborative practice agreement is proposed to be included as part of both the Board of Medical Examiners and the Board of Pharmacy rules as an appendix, to provide guidance to physicians and pharmacists as to what information should be included in these agreements. All collaborative practice agreements must be consistent with the sample agreements contained in the Boards' appendices.

Proposed new rules N.J.A.C. 13:35-6.27(d) and (e) and 13:39-13.4(b) and (c) require that any changes, additions or deletions to the agreements must be submitted to a licensee's respective Board upon request. A physician is also required to establish a method for monitoring compliance with the collaborative practice agreement and the clinical outcomes of the patients.

Proposed new rules N.J.A.C. 13:35-6.27(f) and 13:39-13.5 provide that physicians and pharmacists must jointly create collaborative practice protocols for each type of collaborative drug therapy management authorized by the physician under the agreement. These protocols must be consistent with commonly accepted medical standards and practices and must be submitted for review to the Board of Medical Examiners and the Board of Pharmacy upon request. Protocols must be signed and dated by both the physician and the pharmacist. The proposed new rules provide that the protocols are to be initiated and utilized at the sole discretion of the physician for a specific patient. The protocols must specify when physician notification is required, the physician chart update interval and an appropriate time frame within which the pharmacist must notify the physician of any change in dose, duration or frequency of prescribed medication. In addition, the protocol must establish requirements concerning physician notification of any adverse event. Copies of the protocols must be available at both the physician and pharmacist practice sites and must be reviewed annually by the physician and the pharmacist.

Proposed new rules N.J.A.C. 13:35-6.27(g) and 13:39-13.6 require physicians and pharmacists to obtain a patient's informed consent prior to collaboratively managing the patient's care. The written informed consent document, which must be signed by the patient, must clearly identify the risks and benefits of collaborative drug therapy management. The document must also provide notice to the patient that covering physicians and/or pharmacists may be used in the management of the patient's care and that certain services provided to the patient under collaborative management may not be covered by the patient's insurance.

A collaborative practice agreement may be terminated at any time by either the physician or the pharmacist under proposed new rules N.J.A.C. 13:35-6.27(h) and 13:39-13.4(d). The termination must be in writing and all patients who are undergoing collaborative drug therapy management under the agreement must be notified of the termination.

Proposed new rules N.J.A.C. 13:35-6.27(i), (j) and (k) and 13:39-13.7 provide that collaborative drug therapy management must address an individual patient's specific condition or disease and specify the functions a pharmacist may perform, which may include the following: collecting, analyzing and monitoring patient data; ordering or performing certain laboratory tests; ordering clinical tests; modifying, continuing or discontinuing drug or device therapy; and therapeutic drug monitoring with appropriate modification to dose, dosage regimen, dosage forms or route of administration. The interpretation of clinical or laboratory tests may only be performed by a pharmacist in direct consultation with a physician pursuant to proposed new rules N.J.A.C. 13:35-6.27(l) and 13:39-13.7. Proposed new rules N.J.A.C. 13:35-6.27(m) and 13:39-13.7 prohibit collaborative drug therapy management from including therapeutic interchange at the time of dispensing without the prior, specific informed consent of the patient and the physician.

Participation in or withdrawal from a collaborative practice agreement is voluntary on the part of the physician, pharmacist and individual patient pursuant to proposed new rules N.J.A.C. 13:35-6.27(n) and (o) and 13:39-13.8. All records relating to a collaborative practice agreement must be maintained by both the physician and the pharmacist in either hard copy or electronic form for no less than seven years from the date of termination of the agreement and must be supplied to the licensee's respective Board upon request under proposed new rules N.J.A.C. 13:35-6.27(p) and 13:39-13.4(e). Any violation of the collaborative practice agreement or its protocols on the part of the physician and/or the pharmacist may be deemed professional misconduct and may subject the physician and/or the pharmacist to discipline under proposed new rules N.J.A.C. 13:35-6.27(q) and 13:39-13.9.

The Board of Medical Examiners and the Board of Pharmacy have provided a 60-day comment period for this notice of proposal. Therefore, this notice is excepted from the rulemaking calendar requirement pursuant to N.J.A.C. 1:30-3.3(a)5.

Social Impact

The Board of Medical Examiners and the Board of Pharmacy believe that proposed new rules N.J.A.C. 13:35-6.27 and 13:39-13 may have a positive impact upon physicians and pharmacists who wish to engage in collaborative drug therapy management by clearly delineating the parameters within which collaborative practice by these licensees may be conducted. The proposed new rules may also benefit the patients of physicians and pharmacists engaged in collaborative practice to the extent that the new rules will allow these licensees to work together to more effectively and efficiently manage a patient's drug therapy needs. The Boards believe that collaborative drug therapy management may help to decrease a patient's drug-related problems, such as adverse drug [page=4178] reactions, drug interactions and over or under-utilization of medications. Collaborative drug therapy management will help to foster the optimal use of prescription medications, which may result in an overall reduction in the number of physician office visits a patient must make for the management of chronic diseases.

Economic Impact

The Board of Medical Examiners and the Board of Pharmacy believe that proposed new rules N.J.A.C. 13:35-6.27 and 13:39-13 may have an economic impact upon physicians and pharmacists who wish to engage in collaborative practice to the extent that these licensees may incur administrative costs associated with submitting collaborative practice documentation to their respective Boards. The maintenance of this documentation, in addition to the maintenance of patient records for the time frames specified in the proposed new rules, may also result in administrative costs for physicians and pharmacists. In addition, pharmacists wishing to engage in collaborative drug therapy management may incur costs associated with meeting the educational or experiential qualifications necessary to obtain Board of Pharmacy approval for participation in collaborative practice.

The proposed new rules may also have a beneficial economic impact on patients who agree to have their drug therapy managed by a physician and pharmacist working in collaboration. These patients may experience a reduction in their healthcare costs to the extent that proper drug therapy management may decrease the number of physician office visits patient must make for the management of chronic diseases.

Federal Standards Statement

A Federal Standards analysis is not required because proposed new rules N.J.A.C. 13:35-6.27 and 13:39-13 are governed by N.J.S.A. 45:14-41, 48(a).4, 61 and 62 of the Pharmacy Practice Act. The proposed new rules are not subject to any Federal requirements or standards.

Jobs Impact

The Board of Medical Examiners and the Board of Pharmacy do not believe that proposed new rules N.J.A.C. 13:35-6.27 and 13:39-13 will result in the creation or loss of jobs in the State.

Agriculture Industry Impact

Proposed new rules N.J.A.C. 13:35-6.27 and 13:39-13 will have no impact on the agriculture industry in the State.

Regulatory Flexibility Analysis

Currently, the Board of Medical Examiners licenses approximately 32,000 physicians. The Board of Pharmacy licenses approximately 13,800 pharmacists. If licensees of both Boards are considered "small businesses" within the meaning of the Regulatory Flexibility Act, N.J.S.A. 52:14B-16 et seq., then the following analysis applies.

Proposed new rules N.J.A.C. 13:35-6.27 and 13:39-13 will not impose any reporting requirements, but will impose various recordkeeping and compliance requirements upon licensees of the Board of Medical Examiners and the Board of Pharmacy who choose to enter into collaborative practice agreements. These requirements are discussed in the Summary and Economic Impact statements above.

No additional professional services will be needed to comply with the proposed new rules. The costs of compliance with the proposed new rules are discussed in the Economic Impact statement above. The Boards believe that the proposed new rules should be uniformly applied to all physicians and pharmacists engaging in collaborative practice in order to ensure the health, safety and welfare of the general public in the provision of drug therapy management services by such licensees. Therefore, no differing compliance requirements for any physicians and/or pharmacists are provided based upon the size of the business.

Smart Growth Impact

The Board of Medical Examiners and the Board of Pharmacy do not believe that proposed new rules N.J.A.C. 13:35-6.27 and 13:39-13 will have any impact upon the achievement of smart growth or upon the implementation of the State Development and Redevelopment Plan.

Housing Affordability Impact

The proposed new rules will have an insignificant impact on affordable housing in New Jersey and there is an extreme unlikelihood that the regulation would evoke a change in the average costs associated with housing because the proposed rules concern collaborative practice between physicians and pharmacists.

Smart Growth Development Impact

The proposed new rules will have an insignificant impact on smart growth and there is an extreme unlikelihood that the regulation would evoke a change in housing production in Planning Areas 1 or 2 or within designated centers under the State Development and Redevelopment Plan in New Jersey because the proposed rules concern collaborative practice between physicians and pharmacists.

Full text of the proposed new rules follows:

CHAPTER 35

BOARD OF MEDICAL EXAMINERS

SUBCHAPTER 6. GENERAL RULES OF PRACTICE

13:35-6.27 Standards for collaborative practice for drug therapy management with licensed pharmacists

(a) The following words and terms, as used in this subchapter, shall have the following meanings, unless the context clearly indicates otherwise.

"Collaborative drug therapy management" means the cooperative management of a patient's drug, biological and device-related health care needs, pursuant to a written protocol directed on a voluntary basis by a patient's physician with the patient's informed consent, by the patient's physician and a pharmacist who has signed a collaborative practice agreement with the physician.

"Collaborative practice" means that practice whereby one or more physicians have jointly agreed to work in conjunction with one or more pharmacists for the purpose of collaborative drug therapy management of patients.

"Collaborative practice protocol" means a written document that identifies the collaborative drug therapy management actions that a pharmacist is authorized to perform for a patient and is developed jointly by the pharmacist and the physician.

"Informed consent" means the written document that is signed by a patient whereby the patient agrees to collaborative drug therapy management by the patient's physician and a pharmacist who has entered into a collaborative practice agreement with the physician.

"Therapeutic interchange" means the substitution and dispensing of a drug chemically dissimilar from the prescription drug originally prescribed.

(b) A physician may enter into a collaborative practice agreement with one or more licensed pharmacists, as provided in N.J.S.A. 45:14-61 of the Pharmacy Practice Act, provided the collaboration that the physician agrees to conduct with the pharmacist is within the scope of the physician's practice and the pharmacist is authorized to engage in such activities pursuant to Board of Pharmacy requirements set forth at N.J.A.C. 13:39-13.

(c) A physician who engages in collaborative practice with one or more pharmacists shall provide the Board, upon request, with a signed copy of a collaborative practice agreement. The collaborative practice agreement shall be consistent with the example contained in N.J.A.C. 13:35-6.27 Appendix, which is incorporated herein by reference. The written agreement shall:

1. Identify, by name and title, each physician and each pharmacist who is permitted to participate in a patient's collaborative drug therapy management, including all covering physicians and/or pharmacists. The agreement shall establish the means by which the physician and/or pharmacist will be notified about covering practitioners for collaborative practice purposes;

2. Specify the functions and responsibilities, including the scope of practice and authority, to be exercised by the pharmacist;

3. Indicate any restrictions placed on the use of certain types or classes of drugs or drug therapies;

4. Indicate, if appropriate, any diagnosis or types of diseases that are specifically included or excluded;

[page=4179] 5. Include copies of all protocols to be used in the collaborative practice;

6. Contain an effective date for the agreement; and

7. Be signed and dated by the physician(s) and pharmacist(s).

(d) Any changes, additions or deletions to the collaborative practice agreement shall be submitted to the Board upon request.

(e) The physician shall establish a method for monitoring both the compliance with the collaborative practice agreement and the clinical outcomes of the patients.

(f) Collaborative practice protocols shall be developed for each different type of collaborative drug therapy management authorized by the physician under the collaborative practice agreement and shall identify those activities that may be performed by the collaborating pharmacist. Each protocol shall:

1. Be jointly developed by the physician and the pharmacist, consistent with standards and practices that are deemed commonly accepted and recognized by national standard setting organizations, or national or State professional organizations of the same discipline as the treating physician, and signed and dated by both the physician and the pharmacist;

2. Be initiated and utilized at the sole discretion of the physician for a specific patient;

3. Be agreed to by both the physician and the pharmacist with the written informed consent of the patient consistent with (g) below;

4. Be available at the practice sites of the pharmacist and physician and made available at each site to the patient;

5. Establish the means by which the patient will be advised of the right to elect to participate in and withdraw from the collaborative drug therapy management;

6. Establish when physician notification is required, the physician chart update interval and an appropriate time frame within which the pharmacist shall notify the physician of any change in dose, duration or frequency of medication prescribed. Written notification, by either facsimile or electronic means, shall be provided to the physician no later than eight hours after any change in prescribed medication is made by the pharmacist;

7. Identify the method and time frame for notification of the physician if an adverse event occurs; and

8. Be reviewed at least once per year by the parties to determine whether the protocol should be renewed, modified or terminated.

(g) Written informed consent shall be obtained from each individual patient participating in collaborative drug therapy management. The written informed consent shall:

1. Contain the specific patient's name;

2. Identify the risks and benefits of collaborative drug therapy management, including the fact that services provided under collaborative drug therapy management may not be covered by the patient's insurance provider;

3. Identify the fact that covering physicians and/or pharmacists may be utilized in the collaborative drug therapy management of the patient's care; and

4. Be signed and dated by the patient.

(h) The collaborative practice agreement may be terminated at any time by either the physician or the pharmacist by written documentation. Upon termination of a collaborative practice agreement, the physician and the pharmacist shall provide notice to each individual patient who is undergoing collaborative drug therapy management of the termination. Upon termination of the agreement, the patient's informed consent for collaborative drug therapy management under the agreement shall be voided.

(i) Collaborative drug therapy management shall be between a single patient, the physician and the pharmacist and shall address that patient's specific condition, disease or diseases.

(j) Collaborative drug therapy management may include the collecting, analyzing and monitoring of patient data; ordering or performing of laboratory tests based on the standing orders of a physician as set forth in the written collaborative practice protocols, consistent with (k) below; ordering of clinical tests based on the standing orders of a physician as set forth in the written collaborative practice protocols; modifying, continuing or discontinuing drug or device therapy; and therapeutic drug monitoring with appropriate modification to dose, dosage regimen, dosage forms or route of administration.

(k) Only those laboratory tests that are granted waived status in accordance with the provisions of the "New Jersey Clinical Laboratory Improvement Act," P.L. 1975, c. 166 (N.J.S.A. 45:9-42.26 et seq.) and Department of Health and Senior Services rules set forth at N.J.A.C. 8:44 may be performed by the pharmacist. For purposes of this section, the only laboratory tests granted waived status are the following:

1. Dipstick or tablet urinalysis (non-automated);

2. Fecal occult blood;

3. Ovulation test/visual color comparison tests for luteinizing hormone;

4. Urine pregnancy/visual color comparison tests;

5. Erthrocyte sedimentation rate (non-automated);

6. Hemoglobin copper sulfate (non-automated);

7. Spun microhematocrit; and

8. Blood glucose by monitoring devices approved for home use by the Federal Food and Drug Administration.

(l) The interpretation of clinical or laboratory tests under a written collaborative practice protocol shall only be performed by a pharmacist in direct consultation with a physician.

(m) Collaborative drug therapy management shall not include therapeutic interchange at the time of dispensing without the prior, specific informed consent of the patient and the patient's physician.

(n) Participation in, or withdrawal from, a collaborative practice agreement shall be voluntary on the part of a physician and a pharmacist.

(o) Participation in, or withdrawal from, collaborative drug therapy management shall be voluntary on the part of the individual patient.

(p) All records relating to a collaborative practice agreement shall be maintained in either hard copy or electronic form for a period of not less than seven years from the date of termination of the agreement and shall be supplied to the Board upon request.

(q) Any inappropriate professional behavior or any violation of the collaborative practice agreement or protocols on the part of the physician may be deemed professional misconduct and may subject the physician to discipline consistent with N.J.S.A. 45:1-21.

APPENDIX

Collaborative Practice Agreement

The Pharmacist(s) and Physician(s) listed below are parties to this collaborative practice agreement, through which the pharmacist(s) receives authority, under the supervision of the physician(s) (or covering physician), to perform the functions outlined in accordance with applicable New Jersey statutes and regulations.

Physician:

Name: _______________________ Title: _______________________

Address: ___________________________________________________

Phone Number: ________________ License Number: _____________

Type of Practice/Specialty: _____________________________________

Pharmacist:

Name: _____________________________________________________

Address: ___________________________________________________

Phone Number: _______________ License Number: ______________

Qualifications for Collaborative Practice: _________________________

Describe the functions and responsibilities, including scope and authority, to be exercised by the pharmacist (attach extra sheets if needed):

Indicate any restrictions placed on the use of certain types or classes of drugs or drug therapies under this agreement (attach extra sheets if needed):

If appropriate, indicate any diagnosis, or types of diseases which are specifically included or excluded under this agreement (attach extra sheets if needed):

Attach any protocols to be used in decision making or other activities contemplated under this agreement. This must include a protocol for treating an acute allergic or other adverse reaction related to drug therapy. Each protocol must establish when physician notification is required, the [page=4180] time frame within which the pharmacist must notify the physician of any change in dose, duration or frequency of medication prescribed, and the type of pharmacist documentation required. Written notification, by either facsimile or electronic means, shall be provided to the physician no later than eight hours after any change in prescribed medication is made by the pharmacist.

Physician Signature: _____________________ Date: _______________

Pharmacist Signature: _____________________ Date: ______________

CHAPTER 39

STATE BOARD OF PHARMACY

SUBCHAPTER 13. COLLABORATIVE PRACTICE

13:39-13.1 Purpose and scope

The rules in this subchapter establish standards applicable to all pharmacists who seek to engage in collaborative practice with one or more physicians licensed by the Board of Medical Examiners. Only those activities that have been approved by the collaborating physician, consistent with his or her scope of practice, shall be permitted.

13:39-13.2 Definitions

(a) The following words and terms, as used in this subchapter, shall have the following meanings, unless the context clearly indicates otherwise:

"Certification" means a recognition awarded by a recognized non-government specialty organization to signify that a pharmacist has met predetermined qualifications and to signify to the public that the pharmacist is competent to practice in a designated specialty.

"Collaborative drug therapy management" means the cooperative management of a patient's drug, biological and device-related health care needs, pursuant to a collaborative practice protocol directed on a voluntary basis by a patient's physician with the patient's informed consent, by the patient's physician and a pharmacist who has signed a collaborative practice agreement with the physician.

"Collaborative practice" means that practice of pharmacy whereby one or more pharmacists have jointly agreed to work in conjunction with one or more physicians for the purpose of collaborative drug therapy management of patients, consistent with the requirements of this subchapter.

"Collaborative practice protocol" means a written document that identifies the collaborative drug therapy management actions that a pharmacist is authorized to perform for a patient and is developed jointly by the pharmacist and the physician and meets the requirements outlined in N.J.A.C. 13:39-13.5.

"Credentialing" means the process by which an approved academic institution awards a certificate to signify that the credentialed pharmacist has completed the required courses, examinations or both, that indicate advanced knowledge of a particular area of pharmacy.

"Informed consent" means the written document that is signed by a patient whereby the patient agrees to collaborative drug therapy management by the patient's physician and a pharmacist who has entered into a collaborative practice agreement with the physician.

"Therapeutic interchange" means the substitution and dispensing of a drug chemically dissimilar from the prescription drug originally prescribed.

13:39-13.3 Board approval; pharmacist qualifications; continuing education

(a) In order to enter into an agreement to engage in the collaborative drug therapy management of a patient with a physician licensed in this State, a licensed pharmacist shall be pre-approved by the Board to engage in such activity. In order to obtain such prior Board approval, a pharmacist shall submit documentation to the Board, which establishes that he or she:

1. Has a Doctor of Pharmacy Degree;

2. Is currently certified in a specialty by a nationally recognized authority in the pharmacy practice area specific to the area covered by the collaborative practice agreement. For purposes of this section, a certification shall be deemed current if it was issued with an expiration date and that date has not passed by the date of application to the Board, or if the certification was issued without an expiration date, the certification was obtained within five years of the date of application to the Board;

3. Is currently credentialed in the pharmacy practice area specific to the area covered by the collaborative practice agreement. For purposes of this section, a credential shall be deemed current if it was issued with an expiration date and that date has not passed by the date of application to the Board, or if the credential was issued without an expiration date, the credential was obtained within five years of the date of application to the Board; or

4. Has a minimum of 2,000 hours of experience in a clinical practice setting or a specialty pharmacy specific to the area covered by the collaborative practice agreement, obtained within the two-year period immediately preceding the commencement of the collaborative practice agreement. Documentation submitted in order to substantiate the 2,000 hours of experience shall include:

i. The pharmacist's curriculum vitae;

ii. A job description, including a description of the clinical practice or specialty pharmacy setting, the protocols and guidelines that have been utilized and examples of patients whom the pharmacist has managed;

iii. A letter of support from a physician who has worked with the pharmacist in this area, detailing the pharmacist's responsibilities and role in the management of patients;

iv. Documentation substantiating a residency, if applicable;

v. Documentation concerning the certification and qualifications of the pharmacist's mentor(s), if applicable; and

vi. A notarized affidavit of 2,000 hours of experience.

(b) The Board shall issue an authorization to engage in collaborative drug therapy management to a pharmacist who, upon application to the Board, demonstrates satisfaction of the requirements of (a) above.

(c) A pharmacist granted authorization to engage in collaborative drug therapy management pursuant to this section shall complete a minimum of 10 credits of continuing education every biennial renewal period in the area covered by the collaborative practice agreement to which he or she is a party, consistent with the requirements of N.J.A.C. 13:39-3A.

13:39-13.4 Collaborative practice agreement

(a) A pharmacist who engages in collaborative practice with one or more physicians shall provide the Board, upon request, with a signed copy of a collaborative practice agreement. The collaborative practice agreement shall be consistent with the example contained in N.J.A.C. 13:39-13 Appendix, which is incorporated herein by reference. The written agreement shall:

1. Identify, by name and title, each physician and each pharmacist who is permitted to participate in a patient's collaborative drug therapy management, including all covering physicians and/or pharmacists. The agreement shall establish the means by which the physician and/or pharmacist will be notified about covering practitioners for collaborative practice purposes;

2. Specify the functions and responsibilities, including the scope of practice and authority, to be exercised by the pharmacist;

3. Indicate any restrictions placed on the use of certain types or classes of drugs or drug therapies;

4. Indicate, if appropriate, any diagnosis or types of diseases that are specifically included or excluded;

5. Include copies of all protocols to be used in the collaborative practice;

6. Contain an effective date for the agreement; and

7. Be signed and dated by the physician(s) and pharmacist(s).

(b) Any changes, additions or deletions to the collaborative practice agreement shall be submitted to the Board upon request.

(c) The pharmacist shall cooperate with the method established by the physician for monitoring compliance with the agreement and clinical outcomes of the patients.

(d) The collaborative practice agreement may be terminated at any time by either the physician or the pharmacist by written documentation. Upon termination of a collaborative practice agreement, the physician and the pharmacist shall provide notice to each individual patient who is undergoing collaborative drug therapy management of the termination. [page=4181] Upon termination of the agreement, the patient's informed consent for collaborative drug therapy management under the agreement shall be voided.

(e) All records relating to a collaborative practice agreement shall be maintained in either hard copy or electronic form for a period of not less than seven years from the date of termination of the agreement and shall be supplied to the Board upon request. All records shall be made available to persons authorized to inspect them under State and Federal statutes and regulations. The oldest six years of information shall be maintained in such a manner, so as to be retrievable and readable within two weeks. The most recent one year of information shall be retrievable and readable within one business day. Records not currently in use need not be stored in the pharmacy, but the storage facilities shall be secure. Patient records shall be kept confidential.

13:39-13.5 Collaborative practice protocols

(a) A collaborative practice protocol shall be developed for each different type of collaborative drug therapy management authorized by the physician under the collaborative practice agreement and shall identify those activities that may be performed by the collaborating pharmacist.

(b) Each protocol shall:

1. Be jointly developed by the physician and the pharmacist, consistent with standards and practices that are deemed commonly accepted and recognized by national standard setting organizations, or national or State professional organizations of the same discipline as the treating physician, and be signed and dated by both the physician and the pharmacist;

2. Be initiated and utilized at the sole discretion of the physician for a specific patient;

3. Be agreed to by both the physician and the pharmacist with the written informed consent of the patient, consistent with the requirements of N.J.A.C. 13:39-13.6;

4. Be available at the practice sites of the pharmacist and physician and made available at each site to the patient;

5. Establish the means by which the patient will be advised of the right to elect to participate in and withdraw from the collaborative drug therapy management;

6. Establish when physician notification is required, the physician chart update interval and an appropriate time frame within which the pharmacist shall notify the physician of any change in dose, duration or frequency of medication prescribed. Written notification, by either facsimile or electronic means, shall be provided to the physician no later than eight hours after any change in prescribed medication is made by the pharmacist;

7. Identify the method and time frame for notification of the physician if an adverse event occurs; and

8. Be reviewed at least once per year by the parties to determine whether the protocol should be renewed, modified or terminated.

13:39-13.6 Informed consent for collaborative drug therapy management

(a) Written informed consent shall be obtained from each individual patient participating in collaborative drug therapy management. The written informed consent shall:

1. Contain the specific patient's name;

2. Identify the risks and benefits of collaborative drug therapy management, including the fact that services provided under collaborative drug therapy management may not be covered by the patient's insurance provider;

3. Identify the fact that covering physicians and/or pharmacists may be utilized in the collaborative drug therapy management of the patient's care; and

4. Be signed and dated by the patient.

13:39-13.7 Scope of collaborative drug therapy management

(a) Collaborative drug therapy management shall be between a single patient's specific physician and the patient's collaborative practice pharmacist(s) and shall address that patient's specific condition, disease or diseases.

(b) Collaborative drug therapy management may include the collecting, analyzing and monitoring of patient data, ordering or performing of laboratory tests based on the standing orders of a physician as set forth in the written collaborative practice protocols, consistent with (c) below; ordering of clinical tests based on the standing orders of a physician as set forth in the written collaborative practice protocols; modifying, continuing or discontinuing drug or device therapy; and therapeutic drug monitoring with appropriate modification to dose, dosage regimen, dosage forms or route of administration.

(c) Only those laboratory tests that are granted waived status in accordance with the provisions of the "New Jersey Clinical Laboratory Improvement Act," P.L. 1975, c. 166 (N.J.S.A. 45:9-42.26 et seq.) and Department of Health and Senior Services rules set forth at N.J.A.C. 8:44 may be performed by the pharmacist. For purposes of this section, the only laboratory tests granted waived status are the following:

1. Dipstick or tablet urinalysis (non-automated);

2. Fecal occult blood;

3. Ovulation test/visual color comparison tests for luteinizing hormone;

4. Urine pregnancy/visual color comparison tests;

5. Erthrocyte sedimentation rate (non-automated);

6. Hemoglobin copper sulfate (non-automated);

7. Spun microhematocrit; and

8. Blood glucose by monitoring devices approved for home use by the Federal Food and Drug Administration.

(d) The interpretation of clinical or laboratory tests under a written collaborative practice protocol shall only be performed by a pharmacist in direct consultation with a physician.

(e) Collaborative drug therapy management shall not include therapeutic interchange at the time of dispensing without the prior, specific informed consent of the patient and the patient's physician. Written confirmation of the consent, which may be by electronic means, shall be maintained at the pharmacy practice site of the collaborating pharmacist.

13:39-13.8 Voluntary participation

(a) Participation in, or withdrawal from, a collaborative practice agreement shall be voluntary on the part of a physician and a pharmacist.

(b) Participation in, or withdrawal from, collaborative drug therapy management shall be voluntary on the part of the individual patient.

13:39-13.9 Failure to comply

Any inappropriate professional behavior or any violation of the collaborative practice agreement or protocols on the part of the pharmacist may be deemed professional misconduct and may subject the pharmacist to discipline consistent with N.J.S.A. 45:1-21.

APPENDIX

Collaborative Practice Agreement

The Pharmacist(s) and Physician(s) listed below are parties to this collaborative practice agreement, through which the pharmacist(s) receives authority, under the supervision of the physician(s) (or covering physician), to perform the functions outlined in accordance with applicable New Jersey statutes and regulations.

Physician:

Name: __________________________ Title: ____________________

Address: ___________________________________________________

Phone Number: _______________ License Number: ______________

Type of Practice/Specialty: _____________________________________

Pharmacist:

Name: _____________________________________________________

Address: ___________________________________________________

Phone Number: _______________ License Number: ______________

Qualifications for Collaborative Practice: _________________________

Describe the functions and responsibilities, including scope and authority, to be exercised by the pharmacist (attach extra sheets if needed):

[page=4182] Indicate any restrictions placed on the use of certain types or classes of drugs or drug therapies under this agreement (attach extra sheets if needed):

If appropriate, indicate any diagnosis, or types of diseases which are specifically included or excluded under this agreement (attach extra sheets if needed):

Attach any protocols to be used in decision making or other activities contemplated under this agreement. This must include a protocol for treating an acute allergic or other adverse reaction related to drug therapy. Each protocol must establish when physician notification is required, the time frame within which the pharmacist must notify the physician of any change in dose, duration or frequency of medication prescribed, and the type of pharmacist documentation required. Written notification, by either facsimile or electronic means, shall be provided to the physician no later than eight hours after any change in prescribed medication is made by the pharmacist.

Physician Signature: ___________________ Date: ________________

Pharmacist Signature: _____________________ Date: ___________



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